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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Unveils Draft Guidance on How to Document IRB Activities

The US Food and Drug Administration (FDA) has joined forces with the Office for Human Research Protections (OHRP) to prepare draft guidance on how to record the activities of institutional review boards (IRBs).

The guidance offers advice for institutions, or in some cases the IRBs themselves, that have to prepare and document IRB activities via minutes, which should include summaries of what occurred during a convened meeting and the IRB’s findings and determinations.

“Minutes provide information to persons not present at the meeting (e.g., institutional officials, regulators, IRB members who could not attend) about the IRB’s decisions and provide documentation of the IRB’s compliance with regulatory requirements. Minutes should be detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations,” the guidance says.

Minutes Details

In documenting the actions taken by an IRB, OHRP and FDA offer more details on the type and amount of information that should be provided in the record of minutes.

One of the key areas is on the actions taken by IRBs, which the guidance says should refer to any IRB vote linked to a proposed research activity, including the number of members voting for, against and abstaining from a vote.

The IRB record should also show that the IRB made all of the findings and determinations required for approval under the regulations, or if a proposed research activity is approved with conditions, the minutes should state the process to be followed to ensure conditions are met.

Also, any IRB action to suspend or terminate the approval of a study at a convened meeting must be summarized in the minutes, the guidance says.

The guidance also notes the importance of keeping accurate records of who attended each convened meeting of the IRB. OHRP and FDA recommend that the minutes include the full names of the IRB members present and participating because in order to review proposed research at a meeting, a majority of the members of the IRB must be present, including at least one member whose primary concerns are in nonscientific areas.

The draft also breaks down what should be included with regard to informed consent, studies involving children, emergency research, device studies, studies involving pregnant women and neonates, studies of prisoners and other considerations.

Noncompliance

The guidance notes that failing to prepare and maintain adequate minutes could result in IRBs being cited in OHRP Determination Letters and FDA warning letters.

The guidance offers examples of noncompliance related to minutes, including:

Minutes are missing.

Minutes lack sufficient detail to show the vote on actions taken by the IRB, including the number of members voting for, against, and abstaining.

Minutes are incomplete and only describe voting actions as “passed unanimously.”

Minutes do not clearly indicate, or contain discrepancies about, what the IRB approved.

The IRB maintains multiple sets of minutes with different information for the same meeting.

Minutes fail to include a summary of the discussion of controverted issues.

Comments and suggestions regarding the draft guidance should be submitted within 60 days of publication in the Federal Register.